1. Field of the Invention.
The present invention relates generally to methods and compositions for the treatment of migraine headaches, trigeminal neuralgia, headaches, and headache disorders. More specifically, the present invention relates to methods of treating migraine headaches, trigeminal neuralgia, headaches and head pain disorders by administering a pharmaceutically suitable composition made with and or containing Thevetin A and or Thevetin B in the form of a nasal spray, or other mode of packaging and administered intranasally. In particular the present invention relates to methods for the treatment and or prophylaxis of migraine headache (migraine), cluster headache, tension type headaches, headache disorders, head pain or trigeminal neuralgia, by administration of Thevetin A and or Thevetin B or a pharmaceutical composition comprising Thevetin A and or Thevetin B to individuals in need of treatment thereof.
2. Description of Related Art
There have been several published literature and patents disclosures that list methods of treating some forms of primary headaches using plants extracts that contains various levels of one or more cardiac glycosides and as expected other bioactive compounds. There are also numerous published literatures that teach the administration of drugs intranasally to treat headaches, neurological disorders and other brain diseases. Example is an article that was published by ScienceDaily, “Breakthroug: Nasal spray may soon replace pills for delivering drugs to the brain” ScienceDaily, 21 May, 2014. This particular article cites a study by Massimilano Di Cagno, Assistant Professor of Department of Physics, Chemistry and Pharmacy at the University of Southern Denmark, who in the article cited above, allegedly advocate the treatment of certain brain diseases by administering drugs intranasally. In the article Massimilano Di Cagno allegedly stated in that “People with brain diseases are often given huge amounts of unnecessary drugs. During a long life, or if you have a chronic disease, this may become problematic to your health”. Massimilano Di Cagno and his colleagues are said to have tested a natural sugar and they reported said that this particular polymer is not only capable of carrying drugs through the nasal wall but also most importantly—releasing the drug where it is needed. “This is an important breakthrough, which will bring us closer to delivering brain drugs by nasal spray” Missimilano Di Cagno, added to his statement. The implication being that pharmaceutical drugs that are used to trait brain related disorders can be administered intranasally or as a nasal spray.
The medicinal use of plants extracts that contains various cardiac glycosides are in published literature. Example, the esteemed journal Bothalia which has been in publication since 1921, and is now publishedas “The African Biodiversity & Conservation”, teaches in PROTA 11 (1)—Bothalia 7: 448, that the plant Acokanthera oppositifolia (also known as “Bushman poison” in English and “Msungu” in Swahili) which contains cardiac glycosides “In South Africa root powder or leaf powder is sniffed to cure headache, while leaf infusion is used as a nasal spray for the same purpose”. Another example of the use of cardiac glycosides as a treatment is the United Patent US-2009/0318374 A1, Harrington (Michael G. Harrington) et al cites the use of various cardiac glycosides intranasally as a method for treating headache, without specifically mentioning Thevetin A and Thevetin B; and we also know that as of date, there is no cure for migraine headache, this makes this distinct invention worthy. No literature or patent(s), both published and or cited herein specifically mentions the use of Thevetin A and or Thevetin B, when used, example, in a pharmaceutically suitable preparation, and used intranasally (eg., a nasal spray) can be used as a treatment for migraine headache or other headaches.